Drug for small­pox ap­proved by FDA

Arkansas Democrat-Gazette - - NEWS -

U.S. reg­u­la­tors Fri­day ap­proved the first treat­ment for small­pox — a deadly dis­ease that was wiped out four decades ago — in case the virus is used in a ter­ror at­tack.

Small­pox, which is highly con­ta­gious, was erad­i­cated world­wide by 1980 af­ter a huge vac­ci­na­tion cam­paign.

But peo­ple born since then haven’t been vac­ci­nated, and small sam­ples of the small­pox virus were saved for re­search pur­poses, leav­ing the pos­si­bil­ity it could be used as a bi­o­log­i­cal weapon.

Maker SIGA Tech­nolo­gies of New York has al­ready de­liv­ered 2 mil­lion treat­ments that will be stock­piled by the gov­ern­ment, which par­tially paid for the devel­op­ment of the drug, called TPOXX.

To test the drug’s ef­fec­tive­ness, mon­keys and rab­bits were in­fected with a sim­i­lar virus and then given the drug. More than 90 per­cent sur­vived, the com­pany said. Its safety was tested in sev­eral hun­dred healthy vol­un­teers, who were not in­fected with small­pox.

Small­pox killed about 300 mil­lion peo­ple world­wide in the 20th cen­tury be­fore its erad­i­ca­tion. Symp­toms in­clude fever, fa­tigue and pus-filled sores. Un­til now, doc­tors could only pro­vide sup­port­ive care such as IV flu­ids and fever reme­dies and iso­late the pa­tients. Vac­ci­na­tion can be used to pre­vent in­fec­tion but it must be done within five days of ex­po­sure to the virus, well be­fore symp­toms ap­pear.

“This new treat­ment af­fords us an ad­di­tional op­tion should small­pox ever be used as a bioweapon,” Dr. Scott Got­tlieb, head of the Food and Drug Ad­min­is­tra­tion, said in a state­ment.

The drug is a cap­sule, taken twice daily for 14 days.

SIGA de­vel­ops vac­cines and medicines for bi­o­log­i­cal, chem­i­cal, ra­di­o­log­i­cal and nu­clear at­tacks. Chief Ex­ec­u­tive Phil Gomez said the com­pany is de­vel­op­ing an in­tra­venous ver­sion and is ex­plor­ing sell­ing the drug to other coun­tries and de­vel­op­ing it to treat other in­fec­tious dis­eases, in­clud­ing mon­key­pox, which African mon­keys can trans­mit to hu­mans.

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